Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 30001–30020 of 38,428 recalls

May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Stripper

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: 200¿M Lithotripsy Fiber- Reusable

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Sureflex 273 Lithotripsy Fiber

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: 365¿M Lithotripsy Fiber- Reusable

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· Cook Inc.

Recalled Item: Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular

The Issue: Cook Inc. is initiating a voluntary recall of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Fiber Stripper

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: 1X1 Cleaving Tiles

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· Cook Inc.

Recalled Item: Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding

The Issue: Cook Inc. is initiating a voluntary recall of

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Sureflex 550 Lithotripsy Fiber

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Tool

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
May 28, 2015· American Medical Systems Innovation Center - Silicon Valley

Recalled Item: Stripper

The Issue: validation data related to cleaning instructions and sterilization

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated